Product code HNO
- Device name
- Keratome, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4370
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K173371 | VisuMax Femtosecond Laser | Carl Zeiss Meditec, Inc. | 2018-04-13 |
| K172994 | EPI K Console | Moria SA | 2017-10-26 |
| K072102 | EPIVISION SL SYSTEM | Gebauer Medizintechnik GmbH | 2009-01-16 |
| K082043 | CARRIAZO-PENDULAR MICROKERATOME | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2008-08-01 |
| K062465 | ZYOPTIX XP EPI SEPARATOR SYSTEM | Bausch & Lomb, Inc. | 2006-09-06 |
| K052891 | HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM | Hawken Industries | 2006-03-23 |
| K051486 | NORWOOD ABBEY CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | 2005-07-06 |
| K043183 | EPI-K | Moria SA | 2005-03-25 |
| K043150 | AMADEUS II EPIKERATOME | Sis Ltd., Surgical Instrument Systems | 2005-01-31 |
| K042083 | MODIFICATION TO VISITOME 20-10 MICROKERATOME | Biovision AG | 2004-11-16 |
| K042810 | CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | 2004-10-28 |
| K041110 | MB 105 MILLENNIUM BLADES | Millennium Biomedical, Inc. | 2004-10-13 |
| K041206 | EPITOME SYSTEM | Gebauer Medizintechnik GmbH | 2004-09-15 |
| K032910 | CARRIAZO PENDULAR | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2004-08-30 |
| K032836 | M3 MICROKERATOME | Moria SA | 2004-06-18 |
| K033457 | M2 COMPATIBLE MICROKERATOME BLADE | Micro Specialties, Inc. | 2004-05-25 |
| K033236 | PRIZM KERATOME BLADE, MODEL MK8512M2 | Surgin Surgical Instrumentation, Inc. | 2004-03-26 |
| K040204 | ZYOPTIX XP MICROKERATOME | Bausch & Lomb, Inc. | 2004-03-22 |
| K033182 | PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD | Surgin Surgical Instrumentation, Inc. | 2004-01-30 |
| K033293 | MED-LOGICS, MODEL ML7090 | Med-Logics, Inc. | 2004-01-13 |
| K032978 | MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME | Ciba Vision Corporation | 2003-10-20 |
| K032297 | DISPOSABLE N-PE MICKROKERATOME BLADES | Oasis Medical, Inc. | 2003-08-26 |
| K031735 | CENTURION SES EPIKERATOME | Ciba Vision Corporation | 2003-08-21 |
| K030401 | DISPOSABLE M2-PE MICROKERATOME BLADES | Oasis Medical, Inc. | 2003-06-19 |
| K030891 | SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK | Surgistar, Inc. | 2003-06-17 |
| K020482 | KERATOME BLADE 200200 & 600600 | Micro Specialties, Inc. | 2002-12-16 |
| K022982 | MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB | Med-Logics, Inc. | 2002-11-15 |
| K022716 | MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB | Med-Logics, Inc. | 2002-10-11 |
| K022205 | DISPOSABLE N-PE MICROKERATOME BLADES | Oasis Medical, Inc. | 2002-10-03 |
| K021640 | HANSATOME EXCELLUS MICROKERATOME | Bausch & Lomb, Inc. | 2002-06-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10810003220346 | NA | MICROSPECIALITIES, INC. | 2019-10-31 |
| 10810003221121 | NA | MICROSPECIALITIES, INC. | 2019-02-13 |
| 10810003221114 | NA | MICROSPECIALITIES, INC. | 2019-02-13 |
| 10810003221107 | NA | MICROSPECIALITIES, INC. | 2019-02-13 |
| 10810003221091 | NA | MICROSPECIALITIES, INC. | 2019-02-13 |
| 10810003221084 | NA | MICROSPECIALITIES, INC. | 2019-02-13 |
| 10810003221077 | NA | MICROSPECIALITIES, INC. | 2019-02-13 |
| 10810003221060 | NA | MICROSPECIALITIES, INC. | 2019-02-13 |
| 10810003221053 | NA | MICROSPECIALITIES, INC. | 2019-02-13 |
| 10810003221046 | NA | MICROSPECIALITIES, INC. | 2019-02-13 |
| 07640167750245 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750351 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750344 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750337 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750320 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750092 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750238 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750221 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750214 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750207 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750191 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750184 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750177 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750160 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750153 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750146 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750139 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750122 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750115 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750108 | Procedure Pack | SIE AG, Surgical Instrument Engineering | 2018-09-14 |